Early Diuresis Following Colorectal Surgery

NCT ID: NCT02351934

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-04-30

Brief Summary

The purpose of this study is to find out if giving a medicine called furosemide, which is a diuretic or water pill, after colon surgery will safely shorten the patient's length of hospital stay.

Detailed Description

This study will assess if administration of a loop diuretic, specifically furosemide, to achieve euvolemia can safely reduce length of stay following colorectal surgery.

Conditions

Colorectal Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Furosemide + Enhanced Recovery after Surgery (ERAS)

Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: DRUG

Celecoxib

Intervention Type: DRUG

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.

Gabapentin

Intervention Type: DRUG

Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.

Enhanced Recovery after Surgery (ERAS)

ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.

Gabapentin

Intervention Type: DRUG

Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.

Interventions

Furosemide

Intervention Type: DRUG

Celecoxib

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.

Intervention Type: DRUG

Gabapentin

Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.

Intervention Type: DRUG

Other Intervention Names

Lasix; Celebrex; Neurontin

Eligibility Criteria

Inclusion Criteria

• All elective colorectal surgeries (CRS) utilizing the enhanced recovery pathway (ERP)
• The surgery involves resection

Exclusion Criteria

• Surgeries involving intraoperative radiation
• Ileostomy closures, when performed as the only surgical intervention
• Surgeries involving multiple disciplines (e.g., colorectal plus general surgery, colorectal plus gynecology surgery) except for colorectal surgeries plus ureteral stent placements.
• Chronic loop diuretic therapy (i.e., bumetanide, torsemide, furosemide, ethacrynic acid) including as needed administration of such therapy
• Patients receiving dialysis
• Creatinine clearance, calculated by the Cockcroft-Gault equation, less than 30 mL/min.
• Inpatient prior to surgery
• Allergy to furosemide
• Allergy to sulfa drugs if the allergy involves anaphylactic reaction
• Lack of serum creatinine concentration within 3 months preceding the surgery AND diagnosis of chronic kidney disease

• Patient's weight on postoperative day (POD) #1 and POD #2 is less than preoperative weight.
• Blood pressure criteria: systolic blood pressure criteria less than 90 mmHg or greater than 30 mmHg below baseline on POD #1 and/or POD #2 immediately prior to administration of study drug.
• Complications within 48 hours of surgery
• Abscess (infected fluid collection, treated with CT drainage)
• Leak (defined by CT drainage or reoperation)
• Wound infection (treated with either antibiotics and/or open packing)
• Bowel obstruction (treated with reoperation)
• Reoperation
• Hemorrhage
• Weight change since admission on POD #1: > 5 kg
• Acute kidney injury on POD #1 and POD#2 defined as serum creatinine (SCr) increase ≥ 0.3 mg/dL or increase to ≥ 150% to 200% (1.5- to 2-fold) from baseline

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ilya M. Danelich, Pharm.D., R.Ph.

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilya Danelich, PharmD, RPh

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

UL1TR000135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-008292

Identifier Type: -

Identifier Source: org_study_id